Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed)

Background
The Ancillary Studies to Ongoing Clinical Projects (R21 Clinical Trial Not Allowed) funding opportunity is issued by the National Institutes of Health (NIH), specifically through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). This grant aims to support time-sensitive ancillary studies that enhance the scientific content and value of ongoing clinical projects. The goal is to leverage existing resources from parent projects to maximize research outcomes related to diseases within the NIAMS portfolio.

Grant Details
This funding opportunity solicits applications for conducting ancillary studies that are time-sensitive and related to the NIAMS mission in conjunction with active, ongoing clinical projects. These parent projects can include interventional clinical trials, observational studies, or disease-specific repositories collecting patient samples or clinical data. Successful applications will enhance understanding of diseases, potentially identifying novel targets for diagnosis, treatment, and prevention.

The ancillary studies must not interfere with parent projects and may involve entire cohorts or selected subsets of participants. They should focus on novel research questions not addressed in the parent project. Examples of acceptable research areas include mechanisms of disease, biomarkers, and methodologies that advance study design. Applications will undergo an accelerated review process.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations (including small businesses), local governments, state governments, tribal governments, and other entities as specified in the eligibility section. Special encouragement is given to institutions serving underrepresented groups such as Hispanic-serving institutions and Historically Black Colleges and Universities (HBCUs). Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The maximum project period for this grant is two years. The scope of the proposed project will determine the specific timeline within this period.

Grant Value
Direct costs are limited to $400,000 over a two-year period, with no more than $250,000 in direct costs allowed in any single year.